BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFLEX 200 LITHOTRIPSY FIBER

    MDR report key: 3201351 · Received June 26, 2013

    Report

    Report Number
    2937094-2013-00709
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 29, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K050108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE MFR REPORT #: 2937094-2013-00707, 2937094-2013-00708.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR SUREFLEX FIBERS "BURNED THROUGH" DURING A PROCEDURE; SMOKE APPEARED AT THE PLUG (PROXIMAL CONNECTOR) AND BROKE IN TWO AT THE END. THE PHYSICIAN WAS UNABLE TO COMPLETELY BREAK UP THE STONE, HOWEVER, DID SEE SOME CHANGES. THE PROCEDURES WAS STOPPED PRIOR TO COMPLETION DUE TO FIBER FAILURE; IT IS UNK THE PROCEDURE WAS COMPLETED. UPON FOLLOW-UP, THE PHYSICIAN REPORTED THAT THE FIRST FIBER WAS CLIPPED BY THE TECHNICIAN WITH THE TOWEL CLIP, DAMAGING THE FIBER. THE NEXT THREE FIBERS WERE JUST NOT PRODUCING ENOUGH ENERGY FOR THE VERY DIFFICULT STONE AND EVENTUALLY, THE FIBERS WOULD BECOME CHARRED AT THE TIP (BURNED THROUGH). THERE WAS NO INJURY REPORTED. THIS REPORT IS FOR THE SECOND FIBER USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290790 SUREFLEX 200 LITHOTRIPSY FIBER POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS S-LLF200TG 2341A

    Patients

    Seq Age Sex Outcome Treatment
    1